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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02967692




Registration number
NCT02967692
Ethics application status
Date submitted
16/11/2016
Date registered
18/11/2016

Titles & IDs
Public title
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Secondary ID [1] 0 0
2016-002794-35
Secondary ID [2] 0 0
CPDR001F2301
Universal Trial Number (UTN)
Trial acronym
COMBI-i
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Spartalizumab
Other interventions - Placebo
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Trametinib

Experimental: Part 1: Safety run-in Cohort - In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).

Experimental: Part 2: Biomarker cohort - In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).

Experimental: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)

Placebo comparator: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)


Treatment: Other: Spartalizumab
Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks

Other interventions: Placebo
Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks

Treatment: Drugs: Dabrafenib
Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.

Treatment: Drugs: Trametinib
Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
Assessment method [1] 0 0
DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs
Timepoint [1] 0 0
Up to 8 weeks (Part 1)
Primary outcome [2] 0 0
Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Assessment method [2] 0 0
Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
Timepoint [2] 0 0
Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
Primary outcome [3] 0 0
Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Assessment method [3] 0 0
Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
Timepoint [3] 0 0
Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
Primary outcome [4] 0 0
Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
Assessment method [4] 0 0
Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
Timepoint [4] 0 0
Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)
Secondary outcome [1] 0 0
Overall Survival (OS)
Assessment method [1] 0 0
Overall survival is defined as the time from date of randomization to date of death due to any cause
Timepoint [1] 0 0
Up to death due to any cause, assessed up to approximately 5 years
Secondary outcome [2] 0 0
Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1
Assessment method [2] 0 0
ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
Timepoint [2] 0 0
Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years
Secondary outcome [3] 0 0
Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1
Assessment method [3] 0 0
DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
Timepoint [3] 0 0
From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)
Secondary outcome [4] 0 0
Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1
Assessment method [4] 0 0
DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Timepoint [4] 0 0
Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year
Secondary outcome [5] 0 0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores
Assessment method [5] 0 0
The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.
Timepoint [5] 0 0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Secondary outcome [6] 0 0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores
Assessment method [6] 0 0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning. The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.
Timepoint [6] 0 0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Secondary outcome [7] 0 0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores
Assessment method [7] 0 0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain. The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.
Timepoint [7] 0 0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Secondary outcome [8] 0 0
Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status
Assessment method [8] 0 0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.
Timepoint [8] 0 0
From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)
Secondary outcome [9] 0 0
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score
Assessment method [9] 0 0
The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma. The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma. The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.
Timepoint [9] 0 0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Secondary outcome [10] 0 0
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Assessment method [10] 0 0
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.
Timepoint [10] 0 0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Secondary outcome [11] 0 0
Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression
Assessment method [11] 0 0
PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment. PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having = 1% expression and a negative status was defined as having \< 1% expression.
Timepoint [11] 0 0
Up to disease progression or death due to any cause, up to 2.8 years (Part 3)
Secondary outcome [12] 0 0
Randomized (Part 3): OS by PD-L1 Expression
Assessment method [12] 0 0
OS is defined as the time from date of randomization to date of death due to any cause. OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having = 1% expression and a negative status is defined as having \< 1% expression.
Timepoint [12] 0 0
Up to death due to any cause, up to 5 years
Secondary outcome [13] 0 0
Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline
Assessment method [13] 0 0
Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Spartalizumab ADA Incidence
Assessment method [14] 0 0
Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
Timepoint [14] 0 0
Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).
Secondary outcome [15] 0 0
Trough Concentration (Ctrough) for Spartalizumab
Assessment method [15] 0 0
Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.
Timepoint [15] 0 0
Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Secondary outcome [16] 0 0
Pre-dose Plasma Concentration for Dabrafenib
Assessment method [16] 0 0
Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.
Timepoint [16] 0 0
Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Secondary outcome [17] 0 0
Pre-dose Plasma Concentration for Trametinib
Assessment method [17] 0 0
Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.
Timepoint [17] 0 0
Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Secondary outcome [18] 0 0
Number of Participants With Dose Interruptions
Assessment method [18] 0 0
Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib
Timepoint [18] 0 0
From baseline to end of treatment, up to 5 years
Secondary outcome [19] 0 0
Number of Participants With Dose Reductions
Assessment method [19] 0 0
Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib
Timepoint [19] 0 0
From baseline to end of treatment, up to 5 years
Secondary outcome [20] 0 0
Relative Dose Intensity
Assessment method [20] 0 0
Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity
Timepoint [20] 0 0
From baseline to end of treatment, up to 5 years

Eligibility
Key inclusion criteria
Inclusion criteria Part 1: Safety run-in

* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
* Measurable disease according to RECIST 1.1
* ECOG performance status = 1

Part 2: Biomarker cohort

* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
* Measurable disease according to RECIST 1.1
* ECOG performance status = 2

Part 3: Double-blind, randomized, placebo-controlled part

* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* ECOG performance status = 2
* Measurable disease according to RECIST 1.1
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1: Safety run-in

* Subjects with uveal or mucosal melanoma
* Any history of CNS metastases
* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen
* Radiation therapy within 4 weeks prior to start of study treatment
* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment

Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part

* Subjects with uveal or mucosal melanoma
* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment
* Radiation therapy within 4 weeks prior to start of study treatment
* Clinically active cerebral melanoma metastasis.
* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment

Other protocol-defined Inclusion/Exclusion may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2024
Sample size
Target
Accrual to date
Final
573
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gateshead
Recruitment hospital [2] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [4] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [5] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
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Nebraska
Country [5] 0 0
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New York
Country [6] 0 0
United States of America
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Pennsylvania
Country [7] 0 0
United States of America
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Tennessee
Country [8] 0 0
United States of America
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Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Argentina
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Buenos Aires
Country [11] 0 0
Argentina
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Santa Fe
Country [12] 0 0
Austria
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Tyrol
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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Austria
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St Poelten
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Belgium
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Brussel
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Belgium
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Bruxelles
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Brazil
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Rio de Janeiro
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Santiago
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Czechia
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Czech Republic
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Czechia
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CZE
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Czechia
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Poruba
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Czechia
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Praha 10
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Czechia
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Praha
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Denmark
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Aarhus N
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France
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Haute Vienne
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Amiens
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Besancon Cedex
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Bobigny Cedex
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Bordeaux Cedex
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Boulogne Billancourt
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Caen
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Clermont Ferrand
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Dijon
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Grenoble
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Le Mans
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France
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Lille
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Lorient
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Lyon
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France
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Marseille
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Mulhouse cedex
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Nice
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France
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Paris 10
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France
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Pierre Benite
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France
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Poitiers
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France
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Reims
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France
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Rouen
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Strasbourg Cedex
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France
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Toulouse
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France
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Vandoeuvre-les-Nancy
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France
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Villejuif
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Germany
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Baden Wuerttemberg
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Germany
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Bavaria
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Chemnitz
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Germany
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Dresden
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Germany
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Duesseldorf
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Germany
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Erfurt
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Germany
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Essen
Country [71] 0 0
Germany
State/province [71] 0 0
Freiburg
Country [72] 0 0
Germany
State/province [72] 0 0
Gera
Country [73] 0 0
Germany
State/province [73] 0 0
Halle S
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Germany
State/province [75] 0 0
Hannover
Country [76] 0 0
Germany
State/province [76] 0 0
Heidelberg
Country [77] 0 0
Germany
State/province [77] 0 0
Homburg
Country [78] 0 0
Germany
State/province [78] 0 0
Kiel
Country [79] 0 0
Germany
State/province [79] 0 0
Leipzig
Country [80] 0 0
Germany
State/province [80] 0 0
Mainz
Country [81] 0 0
Germany
State/province [81] 0 0
Marburg
Country [82] 0 0
Germany
State/province [82] 0 0
Minden
Country [83] 0 0
Germany
State/province [83] 0 0
Muenchen
Country [84] 0 0
Germany
State/province [84] 0 0
Muenster
Country [85] 0 0
Germany
State/province [85] 0 0
Stade
Country [86] 0 0
Germany
State/province [86] 0 0
Tuebingen
Country [87] 0 0
Greece
State/province [87] 0 0
Athens
Country [88] 0 0
Hungary
State/province [88] 0 0
Budapest
Country [89] 0 0
Hungary
State/province [89] 0 0
Debrecen
Country [90] 0 0
Hungary
State/province [90] 0 0
Szeged
Country [91] 0 0
Israel
State/province [91] 0 0
Haifa
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Israel
State/province [92] 0 0
Jerusalem
Country [93] 0 0
Israel
State/province [93] 0 0
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Country [94] 0 0
Italy
State/province [94] 0 0
BA
Country [95] 0 0
Italy
State/province [95] 0 0
BG
Country [96] 0 0
Italy
State/province [96] 0 0
BO
Country [97] 0 0
Italy
State/province [97] 0 0
BS
Country [98] 0 0
Italy
State/province [98] 0 0
FC
Country [99] 0 0
Italy
State/province [99] 0 0
GE
Country [100] 0 0
Italy
State/province [100] 0 0
MB
Country [101] 0 0
Italy
State/province [101] 0 0
MI
Country [102] 0 0
Italy
State/province [102] 0 0
MO
Country [103] 0 0
Italy
State/province [103] 0 0
PD
Country [104] 0 0
Italy
State/province [104] 0 0
RM
Country [105] 0 0
Italy
State/province [105] 0 0
SI
Country [106] 0 0
Italy
State/province [106] 0 0
TO
Country [107] 0 0
Italy
State/province [107] 0 0
VR
Country [108] 0 0
Italy
State/province [108] 0 0
Napoli
Country [109] 0 0
Japan
State/province [109] 0 0
Fukuoka
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Japan
State/province [110] 0 0
Kyoto
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Japan
State/province [111] 0 0
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State/province [112] 0 0
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Gdansk
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Poland
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Lisboa
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Portugal
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Porto
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State/province [123] 0 0
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Russian Federation
State/province [124] 0 0
Moscow
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Russian Federation
State/province [125] 0 0
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Russian Federation
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Russian Federation
State/province [127] 0 0
Samara
Country [128] 0 0
Russian Federation
State/province [128] 0 0
St Petersburg
Country [129] 0 0
Spain
State/province [129] 0 0
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Country [130] 0 0
Spain
State/province [130] 0 0
Asturias
Country [131] 0 0
Spain
State/province [131] 0 0
Cadiz
Country [132] 0 0
Spain
State/province [132] 0 0
Catalunya
Country [133] 0 0
Spain
State/province [133] 0 0
Comunidad Valenciana
Country [134] 0 0
Spain
State/province [134] 0 0
Galicia
Country [135] 0 0
Spain
State/province [135] 0 0
Las Palmas de Gran Canaria
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Sweden
State/province [137] 0 0
Goteborg
Country [138] 0 0
Sweden
State/province [138] 0 0
Lund
Country [139] 0 0
Sweden
State/province [139] 0 0
Stockholm
Country [140] 0 0
Switzerland
State/province [140] 0 0
Aargau
Country [141] 0 0
Switzerland
State/province [141] 0 0
Zuerich
Country [142] 0 0
Thailand
State/province [142] 0 0
Hat Yai
Country [143] 0 0
Thailand
State/province [143] 0 0
Bangkok
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Cornwall
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Surrey
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Leicester
Country [147] 0 0
United Kingdom
State/province [147] 0 0
London
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Manchester
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Middlesbrough
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Preston
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Rickmansworth Road

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02967692